Elbow joint destruction which significantly compromises the activities of daily living ー
Post-traumatic lesions or bone loss contributing to elbow instability -
Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis -
Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain -
Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
Revision arthroplasty

Caution: This device is intended for cemented use only.

Device Description

The Zimmer Nexel total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in multiple sizes and in right and left configurations.

How the Device Functions: The Zimmer Nexel Total Elbow is an implant designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implant is a constrained device assembly and consists of the following components: humeral component, ulnar component, humeral bearing-A, ulnar bearings-B, axle pin and humeral screws.

The Following Scientific Concepts, Design Features and Physical Properties form the Basis for the Zimmer Nexel Total Elbow: The humeral component has a humeral stem designed to be implanted with bone cement into the patient's humeral medullary canal, an anterior flange designed to accept a bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.

Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Zimmer Nexel Total Elbow, based on the provided text:

Based on the provided K123862 510(k) summary, the device is a medical implant (total elbow prosthesis) and the study conducted is non-clinical performance testing for demonstrating substantial equivalence to a predicate device, rather than a clinical study involving human readers or AI. Therefore, many of the requested fields are not applicable in this context.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Defined by Design Control activities demonstrating substantial equivalence to predicate device in terms of safety and efficacy	Meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This was non-clinical performance testing (e.g., fatigue, wear, durability), not a study on a test set of patient data.
Data Provenance: Not applicable. The data came from laboratory testing of the device and its components, not from patient-derived data or specific countries.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. Ground truth for non-clinical performance testing typically refers to engineering specifications, industry standards, and established test methods, rather than expert human interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there was no test set requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

MRMC Study: No. This was non-clinical testing of a physical implant, not an AI-assisted diagnostic tool.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: No. This is physical hardware, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Engineering specifications, industry standards, and established test methodologies for evaluating the mechanical properties, durability, and wear characteristics of the prosthetic components. This typically involves physical measurements against predefined limits.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This was non-clinical testing of a physical implant, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable, as there was no training set. The "ground truth" for the non-clinical testing was based on published standards, internal design specifications, and comparison to the predicate device's known performance.

Summary

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K123862

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MAR 1 2 2013

Image /page/0/Picture/3 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter Z inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.

510(k) Summary of Safety and Effectiveness

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Joanna L. SurmaAssociate Project Manager, Regulatory Affairs
Telephone:	(574) 371-1642
Fax:	(574) 372-4605
Date:	13 December 2012
Trade Name:	Zimmer Nexel Total Elbow
Common Name:	Total Elbow Prosthesis
Classification	21 CFR § 888.3150Elbow joint metal/polymer constrained cemented prosthesis
Product Code:	JDC – Prosthesis, Elbow, Constrained, Cemented
Predicate Device:	Coonrad/Morrey Total Elbow, manufactured by Zimmer,K001989, cleared 25 July 2000
	Coonrad/Morrey Total Elbow, manufactured by Zimmer,K053189, cleared 9 December 2005
Device Description:	The Zimmer Nexel total Elbow is a total elbow prosthesisdesigned for use with bone cement. It is available in multiplesizes and in right and left configurations.
	How the Device Functions: The Zimmer Nexel Total Elbow isan implant designed to replace the articulating surfaces of andrestore motion to the humeroulnar (elbow) joint. The implant is aconstrained device assembly and consists of the followingcomponents: humeral component, ulnar component, humeralbearing-A, ulnar bearings-B, axle pin and humeral screws.
	The Following Scientific Concepts, Design Features andPhysical Properties form the Basis for the Zimmer NexelTotal Elbow: The humeral component has a humeral stemdesigned to be implanted with bone cement into the patient'shumeral medullary canal, an anterior flange designed to accept a

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bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.

Comparison to the Predicate: The proposed device (Zimmer Nexel Total Elbow) and the predicate device (Coonrad/Morrey Total Elbow) have the same intended use and similar indications for use. The proposed device humeral and ulnar components are very similar in terms of materials used and design/dimensions to the predicate device humeral and ulnar components. The primary differences between the proposed and predicate devices are that the proposed device bearing components are made of Vitamin E highly cross-linked polyethylene (the predicate device bearing components are made of ultra-high molecular-weight polyethylene), and the proposed device has bearings that articulate on both the outer and inner diameters of the ulnar eve (the predicate device has bearings that articulate on the inner diameter of the ulnar eye). Additionally, the proposed device uses screws and a 1-part axle pin to fix the bearings in place, while the predicate device uses a 2-part (snap-fit) axle pin.

Intended Use:

Indications for use include:

Elbow joint destruction which significantly compromises the activities of daily living ー
Post-traumatic lesions or bone loss contributing to elbow instability -
Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis -
Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain -
Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
Revision arthroplasty

Caution: This device is intended for cemented use only.

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510(k) Summary of Safety and Effectiveness – Zimmer Nexel Total Elbow

The Zimmer Nexel Total Elbow is substantially equivalent to the Comparison to Predicate Device: predicate device in terms of form and function. The Zimmer Nexel Total Elbow and the predicate device share similar intended uses and indications for use. Non-Clinical Performance Testing Conducted: Performance Data: Stem Fatigue Testing --Wear Testing -Durability Testing Modular Connection Fatigue Testing -Non-Clinical Performance Testing Conclusions:

Non-clinical testing demonstrated that the New Zimmer Total Elbow meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.

In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Letter dated: March 12, 2013

Food and Drug Administratio 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Zimmer, Incorporated % Ms. Joanna L. Surma Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K123862

Trade/Device Name: Zimmer Nexel Total Elbow Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: December 13, 2012 Received: December 14, 2012

Dear Ms. Surma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Joanna L. Surma

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N.INielkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known): ___ K123862

Device Name:

Zimmer Nexel Total Elbow

Indications for Use:

Indications for use include:

Elbow joint destruction which significantly compromises the activities of daily living -
Post-traumatic lesions or bone loss contributing to elbow instability -
Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis
Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain
Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
Revision arthroplasty -

CAUTION: This device is intended for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. { Hanley Ph: D Division of Orthopaedic Devices

Page 1 of 1.

Regulation Number and Section

§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”